Axsome Therapeutics, Inc.
Biopharmaceutical company marketing three FDA-approved central nervous system drugs treating depression, excessive daytime sleepiness and migraine.
From the annual report
BU SINESS. OVERVIEW We are a fully integrated biopharmaceutical company focused on developing innovative medicines for people impacted by central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and developing differentiated products with a focus on novel mechanisms of action, that have the potential to transform patient outcomes. Our innovative CNS portfolio is anchored by three U.S. Food and Drug Administration (FDA) approved commercial products: AUVELITY for the treatment of major depressive disorder (MDD), SUNOSI for the treatment of excessive daytime sleepiness (EDS) associated with obstructive sleep apnea or narcolepsy, and SYMBRAVO for the acute treatment of migraine with or without aura in adults. Total revenues from our three commercial products totaled $638.5 million for 2025, representing 66% annual growth compared to 2024. We are also advancing a deep pipeline of novel product candidates in early- to late-stage development addressing a broad range of serious neurological and psychiatric conditions. Our lead product candidate, AXS-05 (dextromethorphan and bupropion), is currently being developed for the treatment of Alzheimer’s disease (AD) agitation and smoking cessation. In December 2025, the FDA accepted for filing the Company’s supplemental NDA (sNDA) for AXS-05 for the treatment of Alzheimer’s disease agitation. The application was granted Priority Review designation and a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2026.
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